We want to study the effects and cost-effectivity with an randomised controlled trial in which we compare participants with dementia (and their informal caregiver) in daycentres which offer exergaming with participants in daycentres that offer…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the physical activity of the participants with
dementia, which will be measured during the week of the three measuring
moments. For each participant we will register in which physical activities
he/she is engaging (how many a week, and for how long) in the daycarecentre and
at home. The registration will be on paper. With regard to physical
functioning, information will be gathered with a short physical test, the Short
Physical Performances Battery (SPPB; Guralnik et al., 1994).
Secondary outcome
We will gather information about different secondary study parameters with
interviews and tests:
Physical functioning. Information will be gathered with interview questions
based on the Physical Activity Scale for the Elderly (PASE; Washburn et al.
1993) and a few items of the The Older Persons and Informal Caregivers Survey
Minimum Dataset (TOPIC MDS).
Cognitive functioning. This will be measured with the Mini-Mental State
Examination (MMSE; Folstein et al., 1975) and the Trail Making Test (Ashendorf
et al., 2008) during an interview.
Social Functioning. This will be measured with one item of the TOPIC MDS and
one item of the ASCOT (Adult Social Care Outcome Kit; Netten et al., 2012) and
this is part of the interview. Also, the personel of the daycentres will be
asked to fill in one subscale of the Gedragsoverservatieschaal voor de
intramurale Psychogeriatrie (GIP; Verstraten & van Eekelen, 1987), this is to
measure the social functioning in the daycentre.
Behaviour and mood. Information about this will be gathered with the
NeuroPsychiatryInventory (NPI-Q; Cummings et al., 1994). The 12 items of the
translated and validated questionnaire (Kat et al., 2002) will measure the
occurrence and nature of the neuropsychiatric symptoms during the past month.
This will include depression, apathy, sleeping disorders etc. The informal
caregiver will answer the questions of the NPI-Q.
Quality of life of the participants will be measured by the EQ5D-5L (EuroQol
group, 2009), a short questionnaire. It measures mobility, self-care, daily
activities, pain/discomfort, anxiety/depression and subjective evaluation of
health. This list will also be used for the cost-effectiveness analysis.
To determine the fall incident rate we will ask the staff of the daycentre and
the informal caregivers to register the incidents.
The level of motivation for exercising of the participants with dementia will
be measured with the Intrinsic Motivation Inventory (Deci et al. 1994) during
an interview. This list will give information about how participants rate their
interest/enjoyment in the exercise and how much they value it.
The subjective burden of care of the informal caregivers will be measured with
a few items of the TOPIC MDS, the Short Sense of Competence Questionnaire
(SSCQ; Vernooij-Dassen et al. 1999) and the Positive Experience Scale (PES; De
Boer et al., 2012). The SSCQ consist of 7 items with 5 possible answers. It
will show the extent to which the informal caregiver feels able to care for the
person with dementia. The PES consists of 8 items with 4 possible answers,
which measures the positive experiences of care giving. The questions will be
asked during an interview with the caregiver.
We will organise focus groups with the persons involved (participants with
dementia, informal caregivers, staff and game providers) to measure the rate of
approval of the physical activities and to discuss future possibilities.
Factors that are related to physical activities and playing games will be
explored with a few individual questions, which will be answered by the
participant with dementia, the caregiver and the personel of the daycentres. To
measure the Body Mass Index of the participant with dementia, we will determine
the height and weight during the first interview.
For the inventarisation of the costs of exergaming equipment, the form 'Costs
and benefits of applied games' (Heuvelink e.a. 2014) will be used. This will be
done in an interview with the staff of the daycare center at the end of the
trial.
For the inventarisation of implementation aspects of exergaming the Measurement
Instrument for Determinants of Innovations (MIDI-lijst) (TNO) will be used.
This will be done in an interview with the staff of the daycare center at the
end of the trial.
Background summary
Research shows that physical exercise can influence a persons level of fitness,
functioning, health and general well-being in a positive way. Physical
inactivity is related to negative health-outcomes, such as mortality, reduced
well-being and social participation, and a influx in health related cost.
Increasing evidence suggest that physical exercise has a positive effect on the
physical, cognitive, emotional and social functioning of people with dementia.
Despite these benefits, it appears that people with dementia often are
inactive. This could be because they often experience difficulties, for example
orientation problems, that make it hard to do physical activities outside of
their house. These difficulties can also be related to a lack of motivation and
taking initiative.
Exergaming is an innovative way to perform physical exercises in virtual
surroundings. The technology registers the movements of the player and this
influences the game or the surroundings. There are various applications, for
example cycling on a hometrainer where the digital environment on screen
changes with your movements.
Exergaming is expected to be a playful way of exercising which will motivate
people with dementia to engage in physical activities in a pleasant and save
manner. They can maintain or improve their physical, cognitive, emotional and
social functioning.
In recent years various exergaming interventions have been developed. These are
primarily used in daycentres, rehabilitation centres and nursing homes. Small
studies which target people with dementia show that they like exergaming, that
exergaming motivates them to exercise longer and that the videos sometimes
evoke memories, which leads to mental activation. The workload of the staff was
reduced, because the people with dementia were motivated to exercise.
These findings are promising, but there is no study yet that investigates the
effects and cost-effectivity of exergaming in comparison with regular physical
activities. We want to fill this void with the current project.
Study objective
We want to study the effects and cost-effectivity with an randomised controlled
trial in which we compare participants with dementia (and their informal
caregiver) in daycentres which offer exergaming with participants in daycentres
that offer regular activities. The questions we want to answer are:
- Are persons with dementia in daycentres with exergaming more physically
active than persons with dementia in daycentres without exergaming?
- In comparison to regular activities offered in daycentres, does exergaming
have a positive effect on the physical, cognitive, emotional and social
functioning and the quality of life on people with dementia? And does it have a
positive effect on the burden of care as experienced by the
informal caregivers?
- Do people with dementia enjoy the different exergaming activities and is this
related to characteristics of the participant or the context?
- In comparison to regular activities in daycentres, is exergaming
cost-effective for people with dementia?
- How do the persons involved think we can best apply the exergaming
intervention for people with dementia?
If exergaming proves to be cost-effective, we hope to achieve that the
exergaming intervention will be spread successfully. Our goal with this project
is to motivate people with dementia to exercise more and cosequently will
experience positive effects on their wellbeing and the quality of life. We also
hope that this will have a positive effect on the burden of care experienced by
their informal caregiver.
Study design
The study is a randomized controlled trial. We will (if possible) arrange
blocks of centers that are similar to one another. Within the blocks centers
will be randomly assigned to the experimental group (exergaming) or to the
control group (regular activities). Interviews and tests will be scheduled at
the start of the study, after three and after six months.
Intervention
People with dementia who are assigned to the experimental group will
participate in the exergaming intervention. The experimental intervention
consists of interactive cycling in combination with a digital screen. The
daycentres in the experimental group will purchase their own exergaming
devices. They can decide which type of bicycle is the best fit for their
clients and facilities of the centre.
The exergaming activities are open to visit for 5 times a week, during the 6
months of follow-up. The participants with dementia are asked to join the
exergaming activity at least two times a week. The participants in the control
group can join the regular activities in the daycentre.
Study burden and risks
Information will be gathered on three different occasions (at the start, after
three and six months). Trained researchers will interview and test the
participants. The participants with dementia in the experimental group will be
asked to take part of the exergaming activities at least two times a week for
six months.
Informal caregivers will be interviewed at the start of the study, after three
and after six months. During the six months of the study, they will keep a
diary in which they will register their use of health care facilities and their
use of medicine. They will also register this for the person with dementia.
The exergaming intervention is developed to give elderly people a save and
playful way to exercise. We expect that this has a positive effect on the
wellbeing of the participant. However, the researchers will stay alert for any
additional burden or risks for the participants and avoid disadvantageous
situations. We expect that the risks for the participants are negligible.
Overschiestraat 57
Amsterdam 1062HN
NL
Overschiestraat 57
Amsterdam 1062HN
NL
Listed location countries
Age
Inclusion criteria
Persons with mild to moderate dementia (indicator: MMSE between 24 and 10) who are expected to live in the community for at least six more months. ;The informal caregiver of the participant with dementia. He/she is willing to participate in interviews and is willing to keep track of the medical costs of themselves and the participant with dementia.
Exclusion criteria
Living in a nursing home, severe comorbidity, having a terminal disease. ;The informal caregiver is excluded if he/she isn't willing to participate in the research.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58227.029.16 |